Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2013-004105-11-DE
EUCTR2013-004105-11-DE
Active, not recruiting
Not Applicable

A Phase 2, Open-label, Randomized Study to Evaluate Safety and Efficacy of Momelotinib in Subjects with Polycythemia Vera or Essential Thrombocythemia

Gilead Sciences Inc.0 sites80 target enrollmentJanuary 23, 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionssubjects with either polycythemia vera (PV) or essential thrombocythemia (ET)MedDRA version: 17.0Level: PTClassification code 10036057Term: Polycythaemia veraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
subjects with either polycythemia vera (PV) or essential thrombocythemia (ET)
Sponsor
Gilead Sciences Inc.
Enrollment
80
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 23, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \= 18 years old
  • •2\.Diagnosis of either PV or ET as defined by the 2008 WHO Diagnostic Criteria
  • •3\.Requires treatment for PV or ET, in the opinion of the study investigator
  • •4\.Intolerant of, resistant to, or refuses current or available treatment for PV or ET
  • •5\.Direct bilirubin \= 2\.0 x upper limit of normal (ULN)
  • •6\.AST (SGOT) and ALT (SGPT) \= 3X ULN
  • •7\.Calculated creatinine clearance (CrCl) of \= 45 mL/min
  • •8\.Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • •9\.Life expectancy \> 24 weeks
  • •10\.Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years postmenopausal)

Exclusion Criteria

  • •1\.Prior splenectomy
  • •2\.Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the study), active or chronic bleeding event within 4 weeks prior to first dose of IP, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
  • •3\.History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate\-specific antigen for \= 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission (CR), or any other cancer that has been in CR for \= 5 years.
  • •4\.Major surgery within 28 days of first dose of IP
  • •5\.Known positive status for human immunodeficiency virus (HIV)
  • •6\.Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
  • •7\.Myeloproliferative neoplasm\-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of IP
  • •8\.Anagrelide within 7 days prior to the first dose of IP
  • •9\.Unresolved non\-hematologic toxicities from prior therapies that are \> CTCAE Grade 1
  • •10\.Presence of peripheral neuropathy \= Grade 2

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity
CTIS2023-506260-14-00Janssen - Cilag International152
Active, not recruiting
Phase 1
A Clinical Study to evaluate the efficacy and safety of GS-5745 in combination with Nivolumab compared to Nivolumab alone in patients with stomach cancer
EUCTR2016-001402-41-HUGilead Sciences, Inc144
Active, not recruiting
Phase 1
A Clinical Study to evaluate the efficacy and safety of GS-5745 in combination with Nivolumab compared to Nivolumab alone in patients with stomach cancerunresectable or recurrent gastric or gastroesophageal junction adenocarcinomaMedDRA version: 20.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001402-41-ITGILEAD SCIENCES INCORPORATED144
Active, not recruiting
Phase 1
A Clinical Study to evaluate the efficacy and safety of GS-5745 in combination with Nivolumab compared to Nivolumab alone in patients with stomach cancerunresectable or recurrent gastric or gastroesophageal junction adenocarcinomaTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001402-41-BEGilead Sciences, Inc144
Active, not recruiting
Phase 1
A Clinical Study to evaluate the efficacy and safety of GS-5745 in combination with Nivolumab compared to Nivolumab alone in patients with stomach cancer
EUCTR2016-001402-41-DEGilead Sciences, Inc120